CTRI/2025/11/098006 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On:
06/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
Pharmacokinetics, Pharmacodynamics, and Safety study of TOL3022 in Patients with Advanced Prostate Cancer
Scientific Title of Study
An Open-label, Single-dose Bioavailability Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety Following Subcutaneous Injection of TOL3022 in Patients with Advanced Prostate Cancer
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
TOL3022A-101, Version 2.0 dated 29/Aug/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sandeep Singh
Designation
Vice President – Clinical Operations
Affiliation
CBCC Global Research
Address
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle
Ahmadabad GUJARAT 382210 India
Phone
09637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Scientific Query
Name
Dr Sandeep Singh
Designation
Vice President – Clinical Operations
Affiliation
CBCC Global Research
Address
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle
GUJARAT 382210 India
Phone
09637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Public Query
Name
Dr Sandeep Singh
Designation
Vice President – Clinical Operations
Affiliation
CBCC Global Research
Address
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle
GUJARAT 382210 India
Phone
09637555304
Fax
Email
sandeep.singh@cbccusa.com
Source of Monetary or Material Support
Tolmar, Inc.
701 Centre Avenue
Fort Collins, CO 80526 US
Tel No: (970) 212-4500
Primary Sponsor
Name
Tolmar, Inc,
Address
701 Centre Avenue
Fort Collins, CO 80526 US
Tel No: (970) 212-4500
Phone: (970) 212-4500
Fax: (970) 212-4950
Type of Sponsor
Other [Pharmaceutical Industry]
Details of Secondary Sponsor
Name
Address
CBCC Global Research LLP
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle, Ahmedabad – 382210, Gujarat, India.
Asarwa, Ahmedabad-380016, Gujarat, India Ahmadabad GUJARAT
9824086834
drshrenik@gmail.com
Dr Rakesh Sharma
Basavatkaram Indo-American Cancer Hospital & Research Institute
Road No. 10, Banjara Hills, Hyderabad, 500034, Telangana, India Hyderabad TELANGANA
7731037700
rakeshsharma217@gmail.com
Dr Mahantesh G Todakar
Belgavi Institute of Medical Science, Belgavi Department of Urology
3rd floor clinical research department Belgavi Department of Urology, Dr. BR Ambedkar Road, Belgavi- 590001, Karnataka, India. Belgaum KARNATAKA
9449335213
drmahanteshgt@gmail.com
Dr Mangesh Padmanabha Kamath
BGS Global Institute of Medical Sciences,
Research Institute college building 2nd floor, No. 67, BGS Health and Education City, Uttarahali Road, Kengiri, Bangalore-560060, Karnataka, India
Bangalore KARNATAKA
8921219255
drmangeshk.research@gmail.com
Dr Mukesh C Arya
Department of Urology, Uro-Sciences Centre, S. P. Medical College & AG of Hospitals,
Uro-Sciences Centre, Room No. 27 Dimhans, S. P. Medical College & AG of Hospitals, Bikaner-334003, Rajasthan, India Bikaner RAJASTHAN
8543888777
mcarya@yahoo.com
Dr Velavan Kandappan
Erode Cancer Centre Private Ltd.
Room No. 24, 1/393, Velavan Nagar, Perundurai Road, Thindal, Erode-638012, Tamil Nadu, India Erode TAMIL NADU
9842334222
kvels@rediffmail.com
Dr Dinesh Chaudhari
Indrayani Hospital and cancer Institute
Alandi Chakan Road, Alandi Devachi, Tal,Khed, Dist-Pune 412105 Pune MAHARASHTRA
8878892334
drdineshoncosurgeon@gmail.com
Dr Tushar Mule
Marathwada Cancer Hospital& Research Institute,
Plot no2, Dyaneshwar nagar, In front of Stadium, Garkheda, Aurangabad 43 1005 Maharashtra lndia
Aurangabad MAHARASHTRA
9820495558
dr.tusharmchri@gmail.com
Dr Preetam Kalaskar
MOC Cancer Care and Research Centre
1st Floor, Room No. 306, Blue Nile building, Almeda Road, Next to Pinnacle Hospital, Charai Naka, Thane, Maharashtra, India-400601 Thane MAHARASHTRA
8828000863
drpritamkalaskar@mocindia.co.in
Dr Prakash SS
Mysore Medical College and Research Institute, KR Hospital, Dept. of Surgical Oncology,
KR Hospital, Room no:23, Dept. of Surgical Oncology, Irwin Road, Mysore-570001 Karnataka, India Mysore KARNATAKA
9901000559
prakashyesyes@yahoo.com
Dr Nandkishor Raut
Oncolife Cancer Centre Pvt. Ltd
Talegaon General Hospital, OPD, new building ground floor, Talegaon-Chakan Rd, Yashwant Nagar, Talegaon Dabhade, Pune-410506, Maharashtra, India Pune MAHARASHTRA
9404904176
surgeon.nandkishor@gmail.com
Dr Anil Kumar M R
Oncoville Cancer Hospital and Research Centre
Room No: 1, No. 4, 80 Ft. Road, 7th Block, Nagarbhavi 2nd Stage, Bengaluru - 560072, Karnataka, India Bangalore KARNATAKA
9739808502
dranil.onco@gmail.com
Dr Lokesh K N
SRV AGADI Hospital and Research Centre,
OPD Department, Ground Floor, #35, H. Siddaiah Road, Wilson Garden, Bengaluru –560027, Karnataka, India Bangalore KARNATAKA
8971609070
drlokeshsrv@gmail.com
Dr Jitendra Amlani
Urocare Hospital
Vidyanagar main road, Nr. Patel Boarding, Rajkot, Gujarat-360002 Rajkot GUJARAT
Institutional Ethics Committee Human Gokul lifecare private limited
Approved
Basavatkaram Indo-American Cancer Hospital & Research Institute
Approved
Ethics Committee, S. P. Medical College,
Approved
Ikon Ethics Committee for research on Human subject
Approved
Institutional Ethics Committee BGS Global Institute of Medical Sciences
Approved
Institutional Ethics Committee BIMS
Approved
Institutional Ethics Committee Erode Cancer Centre
Approved
Institutional Ethics Committee Mysore Medical College
Approved
Institutional Ethics Committee of OCH and RC
Approved
Institutional Ethics Committee – B. J. Medical College and Civil Hospital
Approved
Institutional Ethics Committee-Onco Life Cancer,
Approved
Medstar Speciality Hospital Ethics Committee
Approved
Mumbai Oncocare Centre IEC Cellular-Cancer Centre Private Limited
Approved
Narasimha Saraswati Medical Foundation Ethics Committee
Approved
Shubham Sudbhawana Super. Hosp. Ethics Committee,
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NA
NA
Intervention
TOL3022 manufactured by Tolmar, Inc.)
Dosage:
Cohort 1: 240 mg /0.70 mL
Cohort 1a: 120mg/ 0.35 ml
Cohort 2: 480mg/ 1.3 ml
Cohort 3b: 360mg/ 1.0ml
Cohort 3a: Loading dose paradigm
Route of Administration: Subcutaneous Injection
Duration of Therapy: 113 Days if Cohort 1 and 2, 169 Days if cohort 3.
Frequency: Single dose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Male
Details
To be eligible for study entry, subjects must meet all of the following criteria during screening:
1. Must be able and willing to provide written informed consent prior to participation and comply with the study protocol and procedures.
2. Is a male patient with histologically confirmed carcinoma of the prostate who is a candidate for androgen deprivation therapy (except for neoadjuvant hormonal therapy).
3. Has an Eastern Cooperative Oncology Group (ECOG) score of two or less.
4. Has a serum testosterone level within the age-specific normal range.
5. Has a prostate-specific antigen (PSA) value of four nanograms per milliliter or higher.
6. Has a hemoglobin level of ten grams per deciliter or higher.
7. Has a life expectancy of at least twelve months.
ExclusionCriteria
Details
Subjects will be excluded from the study if one or more of the following criteria are applicable during screening:
1. Has previously received or is currently receiving hormonal treatment for prostate cancer.
2. Has recently received, within three months prior to screening, or is currently receiving treatment with any drugs (prescription or over-the-counter) that modify the testosterone level.
3. Is currently being treated with a five alpha reductase inhibitor or has had prior use within the last six months.
4. Is a candidate for curative therapy, that is, radical prostatectomy or radiotherapy.
5. Has elevated serum alanine aminotransferase level three times the upper limit of normal or serum total bilirubin level one and a half times the upper limit of normal.
6. Has abnormal laboratory results which, in the judgment of the Investigator, would affect the subject’s health or the outcome of the study.
7. Has a known or suspected hepatic symptomatic biliary disease.
8. Presents with significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, endocrine, hematological, neurological, psychological, or dermatological disorder, or an active infection. In addition, has any other condition such as excessive alcohol or drug abuse (based on subject reported history) that may interfere with study participation or influence the conclusion of the study as judged by the Investigator.
9. Has a current or medical history of congenital long QT syndrome, with a QTc of more than four hundred fifty milliseconds, or the presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within the past twelve months prior to study enrollment.
10. Has a history of severe asthma, defined as a need for daily treatment with oral or inhalation steroids to control the asthma, anaphylactic reactions, angioedema, angioneurotic edema, or Quincke’s edema.
11. Has any known hypersensitivity to any component of TOL3022.
12. Is currently under treatment for any cancers, except for certain skin cancers, other than prostate cancer.
13. Has received an investigational drug within the last three months preceding the screening visit.
14. Has had a loss of three hundred fifty milliliters or more of blood within ninety days prior to receiving the investigational product of the current study.
15. Has a positive serology for hepatitis B, defined as hepatitis B surface antigen or hepatitis B core antibody, hepatitis C virus, or human immunodeficiency virus.
Note: Subjects with a hepatitis B core antibody positive result can be enrolled only if a confirmatory negative test is obtained, suggestive of no active infection currently.
16. Has a mental incapacity or language barrier precluding adequate understanding or cooperation.
17. Male subjects sexually active with a female partner of childbearing potential who are not willing to use one of the following acceptable contraceptive methods from the time of initial screening until six months after receiving TOL3022:
Simultaneous use of a condom and, for the female partner, a hormonal contraceptive such as oral, patch, depot injection, implant, vaginal ring, or intrauterine device, or a non-hormonal intrauterine device.
Simultaneous use of a condom and, for the female partner, a diaphragm or cervical cap with spermicide.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the PK following a single SC injection of TOL3022 in subjects with advanced prostate cancer
Day 1
Day 2
Day 4
Day 6
Day 8
Day 15
Day 22
Day 29
Day 43
Day 57
Day 71
Day 85
Day 99
Day 113
Day 141
Day 169
Secondary Outcome
Outcome
TimePoints
To assess safety & tolerability following a single SC injection of TOL3022 in subjects with advanced prostate cancer
To evaluate the PD following a single SC injection of TOL3022 in subjects with advanced prostate cancer
Day 1
Day 2
Day 4
Day 6
Day 8
Day 15
Day 22
Day 29
Day 43
Day 57
Day 71
Day 85
Day 99
Day 113
Day 141
Day 169
Target Sample Size
Total Sample Size="48" Sample Size from India="48" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is an open label, single dose bioavailability study designed to assess the pharmacokinetics, pharmacodynamics, and safety of TOL3022 after subcutaneous injection in subjects with advanced prostate cancer. A total of 6 to 12 subjects will be enrolled in each cohort.
The study will include two main cohorts and up to two optional cohorts:
Cohort 1: TOL3022 240 mg
Cohort 1a (optional): TOL3022 120 mg
Cohort 2: TOL3022 480 mg
Cohort 3 (optional): One of the following cohorts or Cohort 1a
Cohort 3a: TOL3022 loading dose paradigm
Cohort 3b: TOL3022 360 mg
Progression to the next dose level will be based on review of safety, PK, and available PD data at Week 4 for at least three subjects from Cohort 1.
If the TOL3022 240 mg dose is well tolerated, Cohort 2 (TOL3022 480 mg) will be initiated.
If the TOL3022 240 mg dose is not well tolerated, the next cohort will be a dose de escalation to Cohort 1a (TOL3022 120 mg).
If, after completion of Cohorts 1 and 2, the TOL3022 240 mg dose is well tolerated, shows testosterone suppression for three months or longer, and meets other sponsor defined criteria, Cohort 1a may be initiated as an alternative to Cohort 3a or 3b.
Cohort 3 is an optional cohort consisting of two possible dose levels. Enrollment in Cohorts 3a or 3b will begin only after review of safety, PK, and available PD data from at least six subjects in each of Cohorts 1 and 2.